OSTEONIC CO.,Ltd.

Address:405, 505-2, 505-3, 508, 902, 1004, 1005, 1201, 1202, 1206Ho, 38, Digital-ro 29-gil,Seoul,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (10) Fastener, Fixation, Biodegradable, Soft Tissue (MAI) (8)

Premarket Exempt

No Yes

Clear

Fix2Lock - 08809595976361 Catalog Number :

Device Description : Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(USP#2)(White, White/Blue 1)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MAI, MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976378 Catalog Number :

Device Description : Biocomposite Healmax Medial Anchor '5.25' 3Line(Teleflex)(USP#2)(White, White/b Biocomposite Healmax Medial Anchor '5.25' 3Line(Teleflex)(USP#2)(White, White/blue 1, White/Black)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MAI, MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976385 Catalog Number :

Device Description : PEEK Lateral anchor '4.5' 1Line(Metabiomed)(USP#2)(White/Green)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976392 Catalog Number :

Device Description : PEEK Lateral anchor '5.5' 1Line(Metabiomed)(USP#2)(White/Green)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976408 Catalog Number :

Device Description : Biocomposite Healmax Medial Anchor '4.75' 2Line(USP#2)(White,White/Black)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MAI, MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976422 Catalog Number :

Device Description : Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White, Blue 1)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MAI, MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976439 Catalog Number :

Device Description : Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White/Black, Blue 1)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MAI, MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976446 Catalog Number :

Device Description : Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White/Blue 1, Blue 1)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MAI, MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976453 Catalog Number :

Device Description : Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White/Blue 1, Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White/Blue 1, White/Black)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MAI, MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976460 Catalog Number :

Device Description : Biocomposite Healmax Medial Anchor '4.75' 3Line(Teleflex)(USP#2)(White, White/b Biocomposite Healmax Medial Anchor '4.75' 3Line(Teleflex)(USP#2)(White, White/blue 1, White/Black)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MAI, MBI

Prescription Use : Yes

Device Count : 1

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